Analysis of Standard Versus Barbed Sutures in Primary Total Knee Arthroplasty.

NCT ID: NCT01320371

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 363 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this prospective study is determine if barbed sutures are more efficient, have comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional knotted sutures when used in the closure of primary total knee arthroplasty (TKA).

Barbed suture has been associated with improved closure efficiency and safety in TKA in prior studies. The investigators performed a multicenter randomized controlled trial to determine the efficiency and safety of this technology in TKA. The investigators prospectively randomized 411 patients undergoing primary TKA to either barbed running (n=191) or knotted interrupted suture closure (n=203). Closure time was measured intraoperatively. Cost analysis was based on suture and operating room time costs.

Detailed Description

Total knee arthroplasty (TKA) rates have consistently risen in recent years, and demand is expected to increase by over 600% in the next 20 years. Decreasing reimbursement and available resources make tangible advances in surgical efficiency and outcomes essential in meeting current and future demand. Closure time may be one of the best targets in the push to reduce operative time and cost while increasing operative productivity. Optimizing lengthy, multilayered wound closures in TKA is a promising means for improving both efficiency and outcomes by potentially decreasing wound closure time, reducing postoperative wound complications, and improving cosmetic outcomes.

Running knotless suture technique utilizing barbed suture technology has recently been shown to reduce wound closure time in both total hip and knee arthroplasty in a small, prospective, randomized clinical trial. Barbed suture technology has also facilitated rapid closure and soft-tissue repair in plastic-surgery literature. Very few studies have reported on the use of barbed suture technology for multilayered closure in orthopedics. As a pilot study, the investigators performed a retrospective analysis of consecutive cohorts before and after changing to barbed suture. The investigators believed that our published slight improvement in efficiency and cost savings of a barbed suture closure was underestimated due to the retrospective nature of our pilot study and the investigators therefore elected to proceed forward with a prospective randomized trial. Additionally, in the investigators pilot study we found a potential trend toward lower wound complications with the barbed suture and we wanted to see if this would be borne out in a prospective randomized trial.

The investigators hypothesized that a prospective study would show that barbed sutures would be more efficient, have comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional knotted sutures when used in the closure of primary TKA. Specifically, the investigators hypotheses were as follows: multilayered closure in TKA with barbed suture would be associated with (1) shorter closure times; (2) lower cost; (3) similar closure related perioperative complication rates; and (4) similar Knee Society, cosmesis, and patient satisfaction scores when compared to standard knotted suture closure.

Conditions

Arthropathy of Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Barbed sutures

Barbed sutures are self-anchoring, requiring no knots for wound closure.

No interventions assigned to this group

Knotted sutures

Knotted sutures used for traditional surgical closures.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients greater than 18 years of age
• Undergoing primary total knee arthroplasty
• English speaking

Exclusion Criteria

• Patients less than 18 years of age
• Prior open knee surgery in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty (prior arthroscopic surgery does not exclude a patient from the study)
• Wound or Scar in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Christopher Peters

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Peters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah hopsital

Jeremy Gililland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedics Resident

Locations

Duke University Health System

Durham, North Carolina, United States

Joint Implant Surgeons Inc,

New Albany, Ohio, United States

Scott and White HealthCare

Temple, Texas, United States

University of Utah Orthopedics Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

44725

Identifier Type: -

Identifier Source: org_study_id